The European Commission is proposing an overhaul of pharmaceutical legislation in the European Union. This reform is considered the biggest in more than 20 years and aims to increase agility, flexibility and responsiveness to the needs of citizens and businesses across the EU. The proposed revision will improve the availability, accessibility and affordability of medicines, while supporting innovation and enhancing the competitiveness and attractiveness of the EU pharmaceutical industry. It will also promote higher environmental standards, contributing to a more sustainable future.

The proposed revision includes several important changes to the existing legislation. One of these changes is the introduction of a new category of medicines called "innovative medicines", which will benefit from an accelerated approval process. Another change is the creation of a new framework for cooperation between regulators in different EU countries, aimed at reducing duplication and streamlining procedures. In addition, the revision proposes measures to improve transparency and strengthen pharmacovigilance.

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